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CTRI Number  CTRI/2025/07/090620 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   Are routine pre-operative tests always needed?A study on their effectiveness use and cost in elective surgeries 
Scientific Title of Study   Evaluating the clinical relevance and cost effectiveness of routine pre-operative investigation in elective surgeries: A prospective observational study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavana N B 
Designation  post graduate student 
Affiliation  yenepoya school of allied health sciences 
Address  Yenepoya school of allied health sciences department of anaesthesia and OT technology,Yenepoya(deemed to be university) deralakatte Manglore dakshina kannada Karnataka 575018 india

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7975955399  
Fax    
Email  bhavana.20011023@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Don Zach Cherian 
Designation  Assistant Professor 
Affiliation  Yenepoya School of Allied Health Science 
Address  Department Of Anaesthesiology, Yenepoya Medical College Hospital, Yenepoya(Deemed to be University), Deralakatte Manglore Dakshina kannada Karnataka 575018 india

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9446153342  
Fax    
Email  doncherian1001@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Don Zach Cherian 
Designation  Assistant Professor  
Affiliation  Yenepoya School Of Allied Health Science 
Address  Department Of Anaesthesiology ,Yenepoya Medical College Hospital ,Yenepoya (Deemed to be University),Deralakatte Manglore Dakshina kannada Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9446153342  
Fax    
Email  doncherian1001@gmail.com  
 
Source of Monetary or Material Support  
Yenepoya Medical College Hospital ,(Deemed to be university),Deralakatte Manglore Dakshina Kannada Karnataka 575018 India 
 
Primary Sponsor  
Name  Bhavana N B 
Address  Yenepoya school of allied health science,mudipu campus near surya tech park kayargoli,kurnad post Bantwal 574153 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Don zach cherian  Yenepoya medical college, hospital  Department of Anaesthesiology, yenepoya medical college hospital, yenepoya (Deemed to be university ),Deralakatte Manglore
Dakshina Kannada
KARNATAKA 		 9446153342

doncherian1001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya ethics committee 4  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patient who are undergoing for all elective surgery with ASA physical status 1 and 2 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.patients od ASA 1 and 2
2. Patients of all gender planned for elective surgery will be included in the study
3.the study included all the patients between 19-60 years
4. patients hospitalized for elective surgeries under general anaesthesia or regional anaesthesia will be included in the study  
 
ExclusionCriteria 
Details  1.Patients directly evaluated by the designated anaethesiologist will be excluded from the study
2.Emergency surgeries ,day care surgery ,and pregnant patients will be excluded
3. Diagnostic investigation will be excluded from the study  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the proportion of routine pre-operative tests that adhere to established guidelines like those from the national institute of health and care excellence (NICE) and American society of anaesthesiologists (ASA) status.  This outcome will be assessed in the pre-operative room and as well as in post operative period also  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the cost -effectiveness of routine pre-operative investigations in the elective surgical cases.  This outcome will be assessed in the post -operative room  
To analyze the clinical relevance of abnormal test results in improving peri operative outcomes  This outcome will be assessed in the pre-operative room and as well as in post operative period  
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study will comprise individuals who will attend a pre-anaesthesia check-up(PAC) prior to surgery in the preoperative ward for evaluation and risk stratification before planned elective procedures. Their demographic information, date of arrival in pre-anaesthesia check-up (PAC), American Society of Anaesthesiologist’s (ASA) status, and grade of surgery according to NICE guidelines 2016 will be documented. The participants will be randomly assigned using the envelope method. The number of investigations completed prior to arrival at pre-anaesthesia check-up (PAC), as well as the outcomes of normal and abnormal tests, will be recorded. A test will be judged abnormal if it does not fall within the normal limits established by the institutional laboratory. According to the criteria, the test will be classified as indicated or unindicated. The number of abnormal tests and their significance will be expressed. All the patients will be followed up on subsequent pre-anaesthesia check-up (PAC) visits till one day prior to surgery and the total no. of pre-anaesthesia check-up(PAC) visits, any referral, further investigation and consequent delay will be confirmed pre-operatively. In the post-operative period, changes in the on-going management, alteration in the anaesthetic procedures, or monitoring plan will be noted. An abnormal test was considered impactful if it led to further evaluation, and significant if it altered perioperative management. Unnecessary tests, based on NICE guidelines, will be analyzed for cost implications. Diagnostic investigations will be excluded from this study. Any disease-specific investigation conducted based on a significant patient’s history or clinical investigations will not be regarded significant as they will not constitute regular investigations. A single anaesthesiologist will be responsible for collecting data throughout the trial. The designated anaesthesiologist will not be allowed to filter investigations or intervene in the pre-anaesthesia check-up (PAC) process of colleagues of similar rank. To avoid bias, the surgeon and anaesthesiologist will not be informed about the study. Patients examined by the designated anaesthesiologist will be excluded from the research. 
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